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Rosuvastatin seen slowing artery disease progression: AstraZeneca
UK | Thursday, March 29, 2007, 08:00 Hrs  [IST]

AstraZeneca has announced that the Meteor clinical trial of Crestor is the first study to show a positive effect on atherosclerosis in people with early signs of carotid artery disease and at low risk of coronary heart disease (CHD).

The study, using Crestor (rosuvastatin) 40 mg and presented at 56th Scientific Sessions of the American College of Cardiology, resulted in subjects showing a significantly slower rate of progression of atherosclerosis when compared to placebo. When assessed vs. baseline, no significant progression was observed in the 40 mg rosuvastatin arm over the two-year duration of the study, while significant progression vs. baseline was observed in the placebo arm.

The data demonstrated that the Crestor 40mg patients, with moderately increased LDL ('bad') cholesterol levels (mean 154 mg/dL) and no established atherosclerosis, experienced a 0.0014 mm/yr decrease in the mean maximum carotid intima-media thickness - a marker of atherosclerotic burden, compared to a progression of 0.0131 mm/yr for those on placebo. Crestor 40 mg was well tolerated during the two years of the study.

With completion of this study, Crestor has now been studied across the atherosclerosis disease spectrum, first with Asteroid, which included patients with established coronary artery disease and at a high risk of CHD events, and now with Meteor, which evaluated Crestor in asymptomatic subjects with early disease and at low CHD risk.

"It's exciting to see that by using rosuvastatin we can potentially slow or even stop the disease progression in people with relatively modest atherosclerosis," said lead investigator John R Crouse, III, Professor of Medicine and Public Health Sciences and Associate Director of the Wake Forest University School of Medicine (WFUSM) General Clinical Research Centre. "METEOR provides evidence that the effect of rosuvastatin on dyslipidaemia translates into a beneficial effect on the progression of atherosclerosis."

Atherosclerosis occurs when there is a build-up of fatty or fibrous deposits, to form areas called plaques, in the artery wall. The build-up of plaques causes the artery to narrow and this can reduce the blood supply to vital organs such as the heart and brain, resulting in symptoms such as angina or transient ischaemic attacks. Plaques can also rupture leading to thrombus formation, which can result in a sudden, complete blockage of blood flow. In the heart, this causes a heart attack, and in the brain, this causes a stroke. Atherosclerosis is a progressive disease and the main cause of cardiovascular disease - the number one killer worldwide.

A recently published independent post hoc analysis combining data from four prospective trials, including ASTEROID, showed that by substantially both decreasing LDL-C and increasing HDL-C by more than 7.5 per cent, a beneficial effect on atherosclerosis can be achieved. In METEOR, Crestor was associated with a 48.8 per cent reduction in LDL-C and an 8.0 per cent increase in HDL-C.

These results are consistent with the above finding and provide additional confirmation that the lowering of LDL-C and raising of HDL-C offered by CRESTOR translate into beneficial effects on atherosclerosis.

METEOR (Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin) was a 24-month, randomised, double-blind, placebo-controlled, international study to evaluate the effect of Crestor 40mg in 984 asymptomatic, hypercholesterolaemic patients with a low risk of coronary heart disease and evidence of sub-clinical atherosclerotic disease as determined by a thickened carotid artery wall.

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